Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
This position reports into the Head of Programming.
The Contractor, Senior Programmer / Associate Director, Programming checks complex data for consistency, and aggregates and combines them into clearly organized tables, figures or lists, thus providing quality material which forms the basis for insights as well as informed recommendations and decisions to be made.
The Contractor will support the Data Management, Statistics, Drug Safety, Medical and Clinical Pharmacology functions with the above by developing and writing corresponding SAS programs and documentation.
Review CRFs for adequacy and consistency
Support the establishment and maintenance of Genmab SDTM and ADaM database standards
Perform database standards consistency checks on databases delivered by the preferred DM & Statistics vendor to Genmab
Support specification and pooling of data across clinical trials within the same project
Support in-house production of tables, figures, and listings
Perform sponsor oversight of programming activities on the DM & Statistics vendor
Perform QC on SAS-code or other languages (e.g., R, Python) written by other Genmab colleagues or partners
Support submissions by ensuring that the programming-related part of the file is consistent with current electronic submission standards and guidelines
Support resource planning and outsourcing of programming activities
Support developing and reviewing standard processes and templates
Contribute to knowledge sharing, skill building and good collaboration with stakeholders and colleagues
Contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
Contribute to process improvements
Maintain up-to-date knowledge on relevant regulatory guidelines/requirements
Participate and represent programming in teams and meetings
Moreover, you meet the following professional requirements:
Minimum of a Bachelors' degree
At least 4 years of Pharmaceutical/Biotech SAS programming experience
Experience with SAS/Graph and SAS Macros is a plus
Experience with the CDISC data models
Experience in oncology is preferred
NDA/BLA submission experience is a plus
Ability to plan, organize and prioritize own tasks in a fast paced and changing environment
Good oral and written communication skills
Ability to work independently as well with global teams (internal and external)
Result and goal-oriented and committed to contributing to the overall success of Genmab
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.